Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes

NCT04668612 | Unknown FDA Device

• 1 other identifier: 1.1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.

  To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured.

  14 days

Secondary Outcomes (2)

• Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.

  14 days

• Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus

  14 days

Study Arms (2)

Standard-bolus

ACTIVE COMPARATOR

Standard boluses for all meal

Device: Standard bolus

Dual-bolus

EXPERIMENTAL

Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m

Device: Dual-bolus

Interventions

Dual-bolus DEVICE

Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.

Dual-bolus

Standard bolus DEVICE

Standard boluses for all meals

Standard-bolus

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
• Insulin pump and CGM initiated at least 3 months prior to the recruitment.
• Estimated HbA1c based on the 14-days CGM report above 8.5%.
• Daily insulin dose of more than 0.5 international units per kilogram.

You may not qualify if:

• Subjects with known diabetes complications.
• Elevated tissue transglutaminase IgA antibodies in the last two years.
• Children who developed an acute viral infections during the week preceding the recruitment.
• Basal insulin proportion \> 55% of daily insulin dose.
• Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
• Estimated HbA1c \> 8.5% based on the 14-days CGM report.

Sponsors & Collaborators

• Tartu University Hospital: lead
• Estonian Research Council: collaborator

Study Sites (1)

Tartu University Hospital

Tartu, 51014, Estonia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric endocrinologist, MD, PhD

Model Details: Randomized open-label single-center crossover clinical study

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 16, 2020
• Study Start: September 4, 2020
• Primary Completion: May 20, 2021
• Study Completion: June 30, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)